Packaged Cutout 22.2 mm, xFlex F5410-22

GUDID 00858012005717

Packaged Cutout 22.2 mm, xFlex

Icad, Inc.

Radiation shielding apron
Primary Device ID00858012005717
NIH Device Record Keyde17e93e-bbf3-42c8-b7e5-b53c763eaea0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePackaged Cutout 22.2 mm, xFlex
Version Model Number720820
Catalog NumberF5410-22
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005717 [Primary]

FDA Product Code

KPYShield, Protective, Personnel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2016-09-20

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